Unfortunately, the old Directive imposed very complex bureaucratic and legal limits to the organisation of clinical trials. The effect was that international trials (organised across more than 1 country) in the EU dropped dramatically by 25%. This was particularly detrimental for low incidence cancers (like rare cancers) for which it is difficult to find enough patients in one single country.

The new Regulation shall facilitate the set-up of international clinical trials, which is fundamental for the development of new, effective treatments against cancers, particularly those considerate as rare.